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Formulas

Ketoconazole 1%/Urea 38% Topical Cream

The Ketoconazole 1%/Urea 38% Topical Cream is a specialized semisolid preparation that combines the antifungal properties of ketoconazole with the keratolytic and hydrating effects of urea. This cream is specifically formulated to treat a range of dermatological conditions, including fungal infections such as athlete's foot, ringworm, and jock itch, as well as dry, rough, and scaly skin conditions like eczema, psoriasis, and ichthyosis. The inclusion of urea enhances the cream's moisturizing capability, aiding in the removal of dead skin cells and promoting a healthier skin barrier.

Dispensed in a pump mechanism, this topical cream allows for a convenient and controlled application, ensuring that the precise amount of medication is delivered to the affected area. The pump design also helps to maintain the product's sterility and integrity by minimizing contamination risks. This formulation is intended for localized treatment, providing targeted relief and promoting the absorption of the active ingredients directly into the skin where they are needed most.

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Ketoconazole
Urea
Topical Cream
65aebbe3066512dbc5d4bb9a
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Formula Information

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Ketoconazole 1%/Urea 38% Topical Cream is a specialized compounded medication designed to address specific dermatological conditions. Ketoconazole is an antifungal agent that works by disrupting the cell membrane of fungi, effectively treating infections such as athlete's foot, ringworm, and jock itch, as well as seborrheic dermatitis and tinea versicolor. Its inclusion at a 1% concentration is sufficient to provide the antifungal action needed to combat these conditions without causing undue irritation to the skin.

Urea, at a 38% concentration, acts as a potent keratolytic and hydrating agent. It enhances the penetration of ketoconazole, ensuring that the antifungal agent can reach deeper layers of the skin where the infection may reside. Additionally, urea helps to soften and exfoliate the stratum corneum, the outermost layer of the skin, which can be beneficial in hyperkeratotic conditions. This high concentration of urea is particularly effective in treating dry, scaly skin disorders such as psoriasis, ichthyosis, and xerosis, providing significant hydration and promoting the shedding of dead skin cells.

The cream is formulated as a semisolid preparation, which allows for a smooth and uniform application to the affected areas. The use of a pump mechanism for dispensing the cream ensures that the medication is delivered in a controlled manner, reducing waste and contamination, and improving patient compliance. This dosage form is designed to be user-friendly and is particularly advantageous for patients who may have difficulty with manual dexterity or for those who prefer a cleaner and more convenient method of application.

Patients should be advised to apply the cream as directed by their healthcare provider, typically to clean, dry skin. It is important to use the medication regularly and for the full prescribed duration to achieve the best results, even if symptoms appear to improve. Side effects may include local irritation, stinging, or redness, but these are generally mild and transient. If severe irritation or allergic reactions occur, patients should discontinue use and consult their healthcare provider.

Prescribers considering this formulation for their patients should be aware of the synergistic effects of ketoconazole and urea, as well as the convenience and compliance benefits offered by the pump dispenser. This compounded medication can be tailored to meet the specific needs of individual patients, providing a targeted approach to the treatment of various skin conditions.

If you have any questions or require further information about the Ketoconazole 1%/Urea 38% Topical Cream, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of knowledgeable compounding pharmacists is here to provide support and guidance to both patients and healthcare providers.

Drug Interactions

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Ketoconazole is an antifungal agent that works by disrupting the cell membrane of fungi, leading to the death of the fungal cell. It is commonly used to treat skin infections such as athlete's foot, jock itch, ringworm, and certain kinds of dandruff. Urea is a keratolytic, which means it helps to moisturize and soften the skin by increasing its water content and by breaking down the keratin in the outer layer of the skin, which can help in conditions where the skin is dry or calloused.

When using a topical cream containing Ketoconazole 1% and Urea 38%, it is important to consider potential drug interactions, especially if the patient is using other topical or systemic medications. Ketoconazole can inhibit the enzyme CYP3A4, which is involved in the metabolism of many drugs. While systemic absorption of ketoconazole from topical application is generally minimal, there is still a potential for interaction with systemic medications that are substrates of CYP3A4. These could include certain statins, calcium channel blockers, immunosuppressants, and benzodiazepines, among others. Caution is advised when using this cream in conjunction with such medications, and monitoring for increased effects or side effects of these drugs may be necessary.

Additionally, because ketoconazole can also affect the metabolism of certain corticosteroids, using this cream in combination with topical or systemic corticosteroids may increase the risk of systemic side effects of the steroids. This is particularly important for patients who are using potent corticosteroids or using them over a large area of the body.

Urea, being a keratolytic, can increase the penetration of other topical medications, which could potentially increase their absorption and the risk of systemic side effects. Therefore, caution should be exercised when using this cream in combination with other topical agents, especially those known to have significant systemic absorption or toxicity.

It is also important to consider the potential for irritation or allergic reaction when using this cream, especially in individuals with sensitive skin or a history of allergic reactions to skincare products. Patients should be advised to apply the cream to a small test area of skin before widespread use to ensure they do not experience an adverse reaction.

Patients should be instructed to inform their healthcare providers of all medications they are taking, including over-the-counter drugs and herbal supplements, to avoid potential interactions. If there are any concerns or questions regarding the use of Ketoconazole 1%/Urea 38% Topical Cream or potential drug interactions, patients and prescribers are encouraged to reach out to us for further information and guidance.

How Does it Work

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The Ketoconazole 1%/Urea 38% Topical Cream is a specialized formulation that combines the antifungal properties of ketoconazole with the keratolytic and hydrating effects of urea. This cream is designed to treat a variety of dermatological conditions that benefit from the dual action of these two active ingredients.

Ketoconazole is an imidazole antifungal agent that works by disrupting the synthesis of ergosterol, a vital component of fungal cell membranes. By inhibiting the production of ergosterol, ketoconazole compromises the structural integrity of the fungal cell membrane, leading to cell death. This makes it effective against a broad spectrum of fungi, including dermatophytes and yeasts such as Candida. At a 1% concentration, ketoconazole is potent enough to treat fungal infections like tinea (ringworm), athlete's foot, and seborrheic dermatitis without causing significant side effects.

Urea, on the other hand, serves as a potent keratolytic and moisturizing agent. At a high concentration of 38%, urea helps to break down the protein keratin in the skin, which can lead to the softening and shedding of the outer layer of dead skin cells. This action helps to expose the underlying infected areas, allowing for better penetration of ketoconazole. Additionally, urea is a humectant, meaning it draws moisture into the skin, providing hydration and relief from dryness and scaling often associated with skin infections and conditions like eczema and psoriasis.

The combination of ketoconazole and urea in a topical cream form is particularly beneficial for localized treatment. The semisolid preparation is dispensed in a pump mechanism, which allows for convenient and controlled application. This delivery system ensures that the correct dose is applied to the affected area, minimizing waste and reducing the risk of spreading the infection to other parts of the body or to other individuals.

This formulation is indicated for the treatment of skin conditions where both antifungal action and skin hydration or desquamation are needed. It is particularly useful for conditions such as hyperkeratotic tinea infections, where the thickened skin requires softening for effective antifungal penetration, or for seborrheic dermatitis, where scaling can be reduced while treating the underlying fungal component.

For patients and prescribers considering the use of Ketoconazole 1%/Urea 38% Topical Cream, it is important to apply the cream as directed, usually once or twice daily to the affected area after cleansing. Consistent use as prescribed is crucial for the effectiveness of the treatment. As with any medication, it is essential to discuss any known allergies, existing medical conditions, or concurrent medication use with a healthcare provider to avoid potential interactions and side effects.

If you have any questions or require further information about the Ketoconazole 1%/Urea 38% Topical Cream, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support to ensure the safe and effective use of this formulation.

Other Uses

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Ketoconazole is an antifungal agent primarily used for treating various fungal infections of the skin such as athlete's foot, ringworm, and jock itch. Additionally, due to its anti-inflammatory properties, this compound may also help alleviate symptoms associated with such conditions, including itching, redness, and scaling. Similarly, urea acts as a humectant and keratolytic agent, meaning it helps to increase moisture in the skin and promotes the shedding of dead skin cells, respectively. Therefore, while our semisolid preparation containing ketoconazole 1% and urea 38% is primarily designed to treat fungal infections and skin dryness, it may have supplementary uses as well.

For instance, patients suffering from seborrheic dermatitis or dandruff might find this formulation beneficial due to ketoconazole's effectiveness against the yeast thought to play a role in these conditions. It could be advantageous for symptoms such as scalp flakiness and inflammation when applied as directed to the affected area. The addition of urea enhances the formulation's ability to hydrate the skin, which can be particularly helpful in managing the dryness and flakiness associated with psoriasis. Moreover, the keratolytic action of urea in higher concentrations, such as 38%, can also aid in softening and removing psoriatic scales, thus improving the appearance and comfort of the skin.

While this topical cream's benefits are promising across various conditions, it should be noted that its use should be directed by a physician, especially when being considered for off-label uses. The cream's vehicle is specially designed to deliver the active ingredients in a controlled manner via a pump mechanism, ensuring a consistent dosage with each application. This format is particularly helpful in managing treatment areas that are either difficult to reach or require the patient to self-administer medication with limited physical dexterity.

Patients should always inform their healthcare providers of all other topical or systemic treatments they are using to avoid potential interactions. Also, as with any topical preparation, the potential for local skin reactions or sensitivities should be considered. It is important to speak with a healthcare professional before using this formulation for conditions other than those for which it was prescribed. For further questions or information on the use of this compounded formulation, please reach out to us at Bayview Pharmacy. We are committed to ensuring safe and effective therapy customized to your unique needs.

Frequently Asked Questions

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What is Ketoconazole 1%/Urea 38% Topical Cream used for?

This cream is a compounded formulation used for treating various skin conditions such as fungal infections, dry skin, and other conditions where the combination of ketoconazole's antifungal properties and urea's moisturizing effects are beneficial.

How do you use this topical cream?

To use, apply a thin layer of the cream to the affected area as directed by your healthcare provider. Use the pump mechanism to dispense the product, and spread it gently over the skin.

How often should I apply the Ketoconazole/Urea cream?

The frequency of application depends on the specific instructions provided by your healthcare practitioner. It is typically applied once or twice daily, but you should follow the directions provided to you.

Can I use this cream on any part of my body?

It is recommended to use the Ketoconazole/Urea cream only on the skin areas that your healthcare provider has prescribed it for. Avoid contact with eyes, mouth, and other mucous membranes.

What should I do if I miss a dose of the cream?

If you miss a dose, apply the cream as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Can I cover the treated area with a bandage or dressing?

Consult your healthcare provider before covering the treated area. Some conditions may require occlusive dressings, while others may heal better without.

Are there any storage instructions for the Ketoconazole/Urea cream?

Store the cream at room temperature away from heat and direct light. Keep the container tightly closed when not in use. Do not freeze the cream, and keep it out of reach of children.

What side effects can I expect from using this compounded cream?

Common side effects may include mild skin irritation, redness, or peeling. If you experience severe itching, rash, or allergic reaction, contact your healthcare provider immediately.

Can I use other skin products on top of this cream?

It's important to discuss with your healthcare provider before using other skin products in combination with this cream, as there may be interactions.

Should I continue using the cream after my symptoms have resolved?

Continue using the cream for the full course of treatment prescribed by your healthcare provider, even if your symptoms seem to have resolved, to prevent recurrence of the infection.

Is it safe to use the Ketoconazole/Urea cream during pregnancy or while breastfeeding?

Before using this cream, inform your healthcare provider if you are pregnant or breastfeeding. They will assess the benefits against any potential risks to determine if it is safe for you to use.

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Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.

No compounded medications are reviewed by the FDA for safety or efficacy.